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NCT00225225 · ClinicalTrials.gov registry record · NA
Rosiglitazone-Induced Weight Gain
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT00225225: Clinical Trial NA study, sponsored by Stanford University.
NCT00225225 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 45 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00225225, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
Study Summary
Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and non-fatal coronary heart disease events in these patients, long-term glycemic control is of great importance. TZDs improves glycemic control in patients with type 2 DM as well as enhances their insulin-mediated glucose disposal. However, the improvement of glycemic control seen with TZDs may be blunted in the long run by weight gain. Previous data on weight gain during TZD therapy in patients with type 2 DM is very sparse. It is generally assumed that an increase in adipocyte differentiation is the cause of weight gain in association with TZD treatment which may limit their use. Increased body weight assumed to compromise the positive effects of treatment. There is also a theoretical concern that, with the development of new adipocytes, future weight loss may be difficult. However, if weight gain is primarily due to failure to adjust caloric intake in proportion to the decrease in urinary glucose loss, it is totally preventable. It has been previously shown that improvement of glycemia favored weight gain by decreasing the energy loss in the urine as glucose. Severity of weight gain appears to be proportional to the level of glycemic control achieved. The overall goal of the proposed research is to provide the experimental evidence for the later alternative by showing that the modest weight gain that takes place in association with effective rosiglitazone treatment of hyperglycemic patients with type 2 DM is primarily due to its therapeutic efficacy. More specifically, by decreasing the caloric intake in proportion to a decrease in urinary glucose loss associated with improved glycemic control, we will be able to prevent significant weight gain following Rosiglitazone treatment. In order to provide an optimal dietary modification that can be universally applied to TZD-treated patients in clinical practice, we will have a group with a fixed amount of caloric restriction p
Interventions
- DRUG Rosiglitazone
- BEHAVIORAL dietary recommendation for weight maintenance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2002-10 |
| Est. Completion | 2005-09 |
| Phase | NA |
Why NCT00225225 stopped before completion
NCT00225225 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Rosiglitazone is the first listed.
NCT00225225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00225225 about?
NCT00225225 is a clinical study titled "Rosiglitazone-Induced Weight Gain". Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and non-fatal coronary heart disease events in these patients, long-term glycemic control is of great importance. TZDs improves glycemic control in patients with type 2 DM as well as enhances their insulin-medi...
What is the current status of trial NCT00225225?
This trial is currently terminated. It is a NA study. The enrollment target is 45 participants. The study started on 2002-10. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00225225?
The interventions under investigation include: Rosiglitazone (DRUG), dietary recommendation for weight maintenance (BEHAVIORAL).
Who is sponsoring clinical trial NCT00225225?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00225225's enrollment target sits among peer trials
45 1411th of 2000 higher than 578 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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